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Dentium Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K213599SuperLineFebruary 23, 2022
K193341iCTmotor (WL-1)September 4, 2020
K192436Healing Abutments and Cover ScrewsJanuary 23, 2020
K191634Scan Abutments and Comfort CapsNovember 4, 2019
K172640Dentium Implantium & SuperLine ProstheticsMay 14, 2018
K171622Dentium Ti-BaseJanuary 11, 2018
K171126Implantium IISeptember 7, 2017
K170384Dentium NR Line CAD/CAM AbutmentsAugust 17, 2017
K160965SuperLineJanuary 13, 2017
K161713Dentium CAD/CAM AbutmentsDecember 16, 2016
K160828Dentium Implantium & SuperLine ProstheticsSeptember 15, 2016
K160483Burn-out Cylinder and Angled Screw AbutmentsAugust 5, 2016
K153268NR Line Implant SystemJuly 20, 2016
K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTSNovember 12, 2014
K112045SIMPLELINE II ABUTMENT SYSTEMJanuary 26, 2012
K111162SLIM ONEBODY SYSTEMJanuary 13, 2012
K102308SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELSNovember 22, 2010
K070228IMPLANTIUM PROSTHETICSNovember 20, 2007
K052957IMPLANTIUM PROSTHETICSJuly 27, 2006
K060500SPEEDY ORTHODONTIC SCREWJune 16, 2006